Description

Dapoxetine Impurity CAS NO 2242008-36-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes for Dapoxetine hydrochloride. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Dapoxetine API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Dapoxetine and to establish appropriate shelf-life and storage conditions.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure every batch meets stringent purity specifications (e.g., ICH Q3A/B guidelines).
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Used in synthetic chemistry research to study the formation mechanism of this impurity and to develop purer synthetic routes for Dapoxetine.

Basic Information

Product Name	Dapoxetine Impurity
CAS No.	2242008-36-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound; Dapoxetine Process Impurity; Dapoxetine Degradant; (3S)-3-(Dimethylamino)-N,N-dimethyl-3-[(1-naphthyl)oxy]propan-1-aminium; N,N,N-Trimethyl-3-[(1-naphthalenyl)oxy]-1-propanaminium; Dapoxetine Impurity (by structure); Dapoxetine EP Impurity; Dapoxetine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Dapoxetine Impurity (CAS 2242008-36-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.